Company ยท FI
Optomed OY
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2018. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 2018 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Optomed OY, FI | HKI |
| Apr 11, 2017 | K163021 | HAAG-STREIT FUNDUS MODULE 300 Optomed OY, FI | HKI |
| Dec 18, 2013 | K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 Optomed OY, FI | HKI |
| May 16, 2011 | K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 Optomed OY, FI | HKI |
| Oct 1, 2009 | K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 Optomed OY, FI | HKI |
| Apr 14, 1999 | K990417 | DERMACOOL Optomed Corp. | GEX |
| Nov 12, 1993 | K923531 | OPTOSCALPEL I LASER SYSTEM Optomed Corp. | HQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||